Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04938830




Registration number
NCT04938830
Ethics application status
Date submitted
22/06/2021
Date registered
24/06/2021

Titles & IDs
Public title
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Scientific title
A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Secondary ID [1] 0 0
MK-1654-007
Secondary ID [2] 0 0
1654-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
RSV Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Clesrovimab
Treatment: Other - Palivizumab
Treatment: Other - Placebo

Experimental: Clesrovimab - Participants will receive intramuscular (IM) injections of clesrovimab and placebo

Active comparator: Palivizumab - Participants will receive IM injections.


Treatment: Other: Clesrovimab
IM injection

Treatment: Other: Palivizumab
IM injection

Treatment: Other: Placebo
IM injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1
Timepoint [1] 0 0
Up to 5 days
Primary outcome [2] 0 0
Participants with solicited daily body temperature with fever in RSV Season 1
Timepoint [2] 0 0
Up to 5 days
Primary outcome [3] 0 0
Participants with solicited systemic AEs in RSV Season 1
Timepoint [3] 0 0
Up to 5 days
Primary outcome [4] 0 0
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
Timepoint [4] 0 0
Up to 42 days
Primary outcome [5] 0 0
Participants with rash AESI in RSV Season 1
Timepoint [5] 0 0
Up to 42 days
Primary outcome [6] 0 0
Participants with non-serious AEs in RSV Season 1
Timepoint [6] 0 0
Up to 42 days
Primary outcome [7] 0 0
Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Timepoint [7] 0 0
Up to 365 days
Secondary outcome [1] 0 0
Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Timepoint [1] 0 0
Up to 150 days
Secondary outcome [2] 0 0
Participants with RSV-associated hospitalization in RSV Season 1
Timepoint [2] 0 0
Up to 150 days
Secondary outcome [3] 0 0
Participants with solicited injection-site AEs in RSV Season 2
Timepoint [3] 0 0
From approximately 393 days up to 400 days
Secondary outcome [4] 0 0
Participants with solicited daily body temperature with fever in RSV Season 2
Timepoint [4] 0 0
From approximately 393 days up to 400 days
Secondary outcome [5] 0 0
Participants with solicited systemic AEs in RSV Season 2
Timepoint [5] 0 0
From approximately 393 days up to 400 days
Secondary outcome [6] 0 0
Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Timepoint [6] 0 0
From approximately 393 days up to 440 days
Secondary outcome [7] 0 0
Participants with rash AESI in RSV Season 2
Timepoint [7] 0 0
From approximately 393 days up to 440 days
Secondary outcome [8] 0 0
Participants with non-serious AEs in RSV Season 2
Timepoint [8] 0 0
From approximately 393 days up to 440 days
Secondary outcome [9] 0 0
Participants with SAEs in RSV Season 2
Timepoint [9] 0 0
From approximately 393 days up to 575 days
Secondary outcome [10] 0 0
Concentration of clesrovimab in RSV Season 1
Timepoint [10] 0 0
Up to 240 days
Secondary outcome [11] 0 0
Concentration of clesrovimab in RSV Season 2
Timepoint [11] 0 0
From approximately 393 days up to 550 days

Eligibility
Key inclusion criteria
* Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
* Is available to complete the follow-up period.
Minimum age
No limit
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Requires mechanical ventilation at time of enrollment.
* Has a life expectancy <6 months.
* Has known hepatic or renal dysfunction, or chronic seizure disorder.
* Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
* Has severe immunodeficiency or is severely immunocompromised.
* Has known hypersensitivity to any component of clesrovimab or palivizumab.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/10/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Mater Misericordiae Limited-Neonatalogy ( Site 0102) - Brisbane
Recruitment hospital [2] 0 0
Telethon Kids Institute-Vaccine Trials Group ( Site 0101) - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Chile
State/province [21] 0 0
Region M. De Santiago
Country [22] 0 0
Colombia
State/province [22] 0 0
Antioquia
Country [23] 0 0
Colombia
State/province [23] 0 0
Atlantico
Country [24] 0 0
Colombia
State/province [24] 0 0
Distrito Capital De Bogota
Country [25] 0 0
Colombia
State/province [25] 0 0
Valle Del Cauca
Country [26] 0 0
Czechia
State/province [26] 0 0
Moravskoslezsky Kraj
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 4
Country [28] 0 0
Finland
State/province [28] 0 0
Mellersta Osterbotten
Country [29] 0 0
Finland
State/province [29] 0 0
Pirkanmaa
Country [30] 0 0
Finland
State/province [30] 0 0
Pohjois-Pohjanmaa
Country [31] 0 0
Finland
State/province [31] 0 0
Sodra Osterbotten
Country [32] 0 0
Finland
State/province [32] 0 0
Uusimaa
Country [33] 0 0
Finland
State/province [33] 0 0
Varsinais-Suomi
Country [34] 0 0
France
State/province [34] 0 0
Aquitaine
Country [35] 0 0
France
State/province [35] 0 0
Calvados
Country [36] 0 0
France
State/province [36] 0 0
Yvelines
Country [37] 0 0
Germany
State/province [37] 0 0
Baden-Wurttemberg
Country [38] 0 0
Germany
State/province [38] 0 0
Bayern
Country [39] 0 0
Germany
State/province [39] 0 0
Niedersachsen
Country [40] 0 0
Germany
State/province [40] 0 0
Nordrhein-Westfalen
Country [41] 0 0
Germany
State/province [41] 0 0
Sachsen
Country [42] 0 0
Germany
State/province [42] 0 0
Schleswig-Holstein
Country [43] 0 0
Greece
State/province [43] 0 0
Attiki
Country [44] 0 0
Greece
State/province [44] 0 0
Kentriki Makedonia
Country [45] 0 0
Hong Kong
State/province [45] 0 0
Shatin
Country [46] 0 0
Hong Kong
State/province [46] 0 0
Tuen Mun
Country [47] 0 0
Hungary
State/province [47] 0 0
Bacs-Kiskun
Country [48] 0 0
Hungary
State/province [48] 0 0
Borsod-Abauj-Zemplen
Country [49] 0 0
Hungary
State/province [49] 0 0
Szabolcs-Szatmar-Bereg
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Debrecen
Country [52] 0 0
Italy
State/province [52] 0 0
Lazio
Country [53] 0 0
Italy
State/province [53] 0 0
Lombardia
Country [54] 0 0
Italy
State/province [54] 0 0
Veneto
Country [55] 0 0
Italy
State/province [55] 0 0
Parma
Country [56] 0 0
Japan
State/province [56] 0 0
Fukuoka
Country [57] 0 0
Japan
State/province [57] 0 0
Gunma
Country [58] 0 0
Japan
State/province [58] 0 0
Ibaraki
Country [59] 0 0
Japan
State/province [59] 0 0
Tokyo
Country [60] 0 0
Japan
State/province [60] 0 0
Shizuoka
Country [61] 0 0
Malaysia
State/province [61] 0 0
Kelantan
Country [62] 0 0
Malaysia
State/province [62] 0 0
Kuala Lumpur
Country [63] 0 0
Malaysia
State/province [63] 0 0
Pulau Pinang
Country [64] 0 0
Malaysia
State/province [64] 0 0
Sabah
Country [65] 0 0
Malaysia
State/province [65] 0 0
Sarawak
Country [66] 0 0
Mexico
State/province [66] 0 0
Distrito Federal
Country [67] 0 0
Mexico
State/province [67] 0 0
Guanajuato
Country [68] 0 0
Mexico
State/province [68] 0 0
Jalisco
Country [69] 0 0
Mexico
State/province [69] 0 0
Durango
Country [70] 0 0
Mexico
State/province [70] 0 0
Oaxaca
Country [71] 0 0
Mexico
State/province [71] 0 0
San Luis Potosi
Country [72] 0 0
New Zealand
State/province [72] 0 0
Wellington
Country [73] 0 0
New Zealand
State/province [73] 0 0
Auckland
Country [74] 0 0
Norway
State/province [74] 0 0
Oslo
Country [75] 0 0
Peru
State/province [75] 0 0
Lima
Country [76] 0 0
Puerto Rico
State/province [76] 0 0
San Juan
Country [77] 0 0
Singapore
State/province [77] 0 0
South West
Country [78] 0 0
South Africa
State/province [78] 0 0
Gauteng
Country [79] 0 0
South Africa
State/province [79] 0 0
Kwazulu-Natal
Country [80] 0 0
South Africa
State/province [80] 0 0
Western Cape
Country [81] 0 0
Spain
State/province [81] 0 0
Asturias
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
La Coruna
Country [84] 0 0
Spain
State/province [84] 0 0
Madrid
Country [85] 0 0
Spain
State/province [85] 0 0
Malaga
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taichung
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taipei
Country [88] 0 0
Taiwan
State/province [88] 0 0
Taoyuan
Country [89] 0 0
Thailand
State/province [89] 0 0
Krung Thep Maha Nakhon
Country [90] 0 0
Thailand
State/province [90] 0 0
Songkhla
Country [91] 0 0
Turkey
State/province [91] 0 0
Adana
Country [92] 0 0
Turkey
State/province [92] 0 0
Ankara
Country [93] 0 0
Turkey
State/province [93] 0 0
Kayseri
Country [94] 0 0
United Kingdom
State/province [94] 0 0
England
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Glasgow City
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Great Britain
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Hampshire
Country [98] 0 0
United Kingdom
State/province [98] 0 0
London, City Of
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Oxfordshire
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04938830